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The problem is that these glowing headlines are based on nothing more than an observational study of about 50 patients in a single intensive care unit in eastern Virginia. In other words, the kind of finding that’s very likely to get reversed when subjected to more rigorous study. It happens all the time.

It’s a fair question to ask if this really deserved air time during Morning Edition, NPR’s flagship morning news program that reaches millions each day. After all, finding an effective treatment for sepsis has eluded doctors for centuries. Wouldn’t it be prudent to wait a little longer to see if this very preliminary case series holds up?

Experts I spoke with questioned the decision to cover the study but said NPR’s piece, headlined “Doctor Turns Up Possible Treatment For Deadly Sepsis,” was appropriately cautious. They said it was a balanced look at the issue and did a good job of pointing out the following:

There have “been many false promises about this condition over the years” so NPR advises approaching the results “with caution”

This is “not the standard way to evaluate a potential new treatment” (no controlled study)

“There have been hundreds of exciting results from sepsis studies that failed in follow-up research”

So, how did all this fuss start?

Dr. Paul Marik is a critical care doctor with Eastern Virginia Medical School. In January of 2016 he was treating a 48-year-old woman with severe sepsis in the intensive care unit at Sentara Norfolk General Hospital. Sepsis occurs when an infection enters the bloodstream, spreads systemically, and triggers a cascading inflammatory response that can lead to widespread, multi-organ failure.

Dr. Marik

When sepsis is severe, anywhere from 15 to 30 percent of patients will die despite the traditional treatment approach of hitting the patients hard with intravenous antibiotics (for the infection) and intravenous fluids (to keep their blood pressure up). This is what Marik’s patient was facing.

Marik had recently read a study out of Virginia Commonwealth University that had shown some promise in using intravenous vitamin C for sepsis. So he improvised a triple cocktail of vitamin C, corticosteroids, and another vitamin, thiamine. The patient improved.

So did others he tried it on. When he found that only 4 out of 47 people (8%) treated this way died in the hospital — compared with 19 out of 47 (40%) who had died before he improvised the triple cocktail — he felt the results were just too promising not to share. That’s when the journal, Chest, decided to publish the results as original research. But is it research?

Dr. O’Brien

“It is research, but it is a very small study,” says Dr. Jim O’Brien, an ICU physician who is also the chairman of the board of directors for the Sepsis Alliance. “It’s an observational study, not a blinded and randomized clinical trial. So we need more rigorous, larger, and well-designed studies to see if the results hold up.”

Why is this story susceptible to hyperbole?

First, sepsis is the number one cause of death among hospitalized patients in this country. It kills nearly a quarter of a million Americans each year, and nearly 8 million people — mostly children — globally. According to to the Agency for Healthcare Research and Quality, sepsis is the most expensive condition treated in U.S. hospitals, costing more than $20 billion in 2011. It also has some of the highest readmission rates of any disease. Add to these numbers the fact that the pharmaceutical industry has invested billions trying to find treatments for sepsis, and you are looking at big numbers all around. Big numbers equals big eyes, and big eyes can mean big click rates and big ratings.

Second, vitamin C may be in your medicine cabinet right now. This realization might tempt some — like this NBC affiliate in Denver — to erroneously conclude that Dr. Marik has “found a simple, inexpensive cure for sepsis.”

Dr. Ross

“There’s this belief that because it is a vitamin there can’t be toxicity,” says Dr. O’Brien. “But it’s still a drug. Still a chemical. We don’t know if there are toxicities or not.”

Dr. Joseph Ross, an internist at Yale University who specializes in health care delivery and quality, says there is another aspect of the vitamin angle to consider:

“I’m a bit more concerned that by highlighting vitamin C as a potentially new ‘game-changing’ therapy for sepsis , the fact that it’s widely available for consumer purchase now –and vitamin and supplement manufacturers are well known to push the boundaries of acceptable advertising — I wouldn’t be surprised to see manufacturers use this story as ‘proof’ that vitamin C is good for infections, and so on.”

But so far the most egregious hype has come from the Eastern Virginia Medical School itself — the school where Dr. Marik is on the staff. It’s alarming when a medical school news release runs a headline like this: “A Cure for Sepsis?” Not only do they go on to describe Dr. Marik’s findings as a “breakthrough ..[it] promises to revolutionize sepsis care worldwide and produce results that are nothing short of astonishing,” but Dr. Marik himself is quoted as saying:

“We haven’t seen a patient die of sepsis since we began using the combination therapy a year ago. We have completely changed the natural history of sepsis.”

What’s really astonishing — disturbing actually — are health care organizations and news outlets that continue to do this: when given the choice between seducing readers with pablum or actually providing them with information in context, many opt for the former. And that is another widespread infection that needs treatment as soon as possible.

Correction 3/28/17: This post initially stated that 4 people treated with the vitamin C protocol died of sepsis. It has been corrected to note that these patients died in the hospital. According to the published study, they did not die of complications of sepsis.

Comments (24)

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Richard Harris

March 28, 2017 at 9:44 am

You incorrectly state that 4 of 47 people died of sepsis in the Chest study. Actually 0 or 47 people died of sepsis; 4 died of underlying conditions, according to the paper. Dr. Marik asserts there has been just one one death from sepsis among 150 patients he has tested. Extraordinary claims require extraordinary evidence, and clearly we don’t have that yet. My story has stimulated great interest in getting studies under way to test this idea quickly. I believe journalism is serving a valuable purpose in that regard. If Dr. Marik’s claims hold up, this would be a major medical advance, and the sooner we know that the better. Likewise if it’s a false lead, that’s valuable information as well.

Kevin Lomangino

March 28, 2017 at 12:57 pm

Thanks for bringing the error to our attention. I’ve added this correction: “This post initially stated that 4 people treated with the vitamin C protocol died of sepsis. It has been corrected to note that these patients died in the hospital. According to the published study, they did not die of complications of sepsis.”

Kevin Lomangino Managing Editor

Brooks Kuhn

March 28, 2017 at 10:32 pm

Bravo! Thank you for your cautious analysis of Dr. Marik’s publication. While undoubtedly intriguing, a single-center, observation study like this should not dictate care (or justify the hyperbolic claims in the media and the conclusions of the paper itself).

Karl Davis

March 29, 2017 at 9:44 am

This isn’t just a statement by one person. He worked with a research hospital, and that hospital backs up his claims. He also has been researching sepsis for years. If you check the Wikipedia page, there are citations of his work going back for years. It’s possible this won’t work, but I bet it does. To say it’s unproven is to claim that going from 30% mortality to losing one patient out of 150 (to sepsis) is not statistically significant, but that’s in the 3.5-4 standard deviation range. Another approach would be to say that it’s all a lie or exaggeration, but it’s hard to get an entire hospital to join in this, or to have roughly 50 deaths and hide them. Another possibility is that there was a sudden change in the causes of sepsis near his hospital at that time that made the cases much easier to recover from, but I find that implausible. The history may have been that “nothing has worked”, but this time it sounds very different. I don’t see a single reason to expect this to fail. Sure, we can have controlled studies, but be prepared for those studies to be cut off early because it’s unethical to let the people in the control arm die or suffer for far longer than needed.

Kevin Lomangino

March 29, 2017 at 11:52 am

Karl,

You are quite optimistic and I hope you are correct. However, there are many reasons to expect that this won’t pan out in more rigorous studies. This is not very different from many other treatments that looked promising at early stages but ultimately proved ineffective or harmful.

Kevin Lomangino Managing Editor

Travis Harris

March 29, 2017 at 1:21 pm

First, I am not a doctor.

That out of the way it seems to me that the possible benefits outweigh the possible harm with this inexpensive treatment — these are very sick people. Why NOT try it?

Dave Brown

March 29, 2017 at 2:06 pm

Skepticism is a good thing. But being reflexively negative may not be. I think we all should be encouraging other research parties to give this therapy a closer look, and produce more data. This new approach to addressing sepsis could be a huge game-changer!

Kevin Lomangino

March 29, 2017 at 2:23 pm

Dave,

I have no problem with encouraging research and producing more data. I have a big problem with touting something as a “cure” to the general public when it hasn’t been adequately tested. That’s not reflexive negativity. That’s just common sense.

Kevin Lomangino Managing Editor

Peter Lipowicz

March 29, 2017 at 8:43 pm

The study deserves all the news it got and more. The announcement of the results is the time to do it. This doctor and this hospital are putting their reputations on the line. They have announced a cure for a real killer medical problem. How is that not headline news? If not now then when? After a dozen studies have been done and it proves out. How about when just one more study proves out? There will never be another media moment with the excitement and promise of the announcement that coincides with the release of the original research. Now we know, if it proves out, just what doctor and hospital is responsible. There is no way for somebody to swoop in with a clinical trial at a larger hospital and take the credit.

John Lasseter

March 30, 2017 at 7:31 am

The article here is is not a cautious analysis but resembles a glass half full appraisal of a possible treatment for sepsis. I understand you don’t like the headlines of a possible cure but that isn’t the only negative your article hits on. It’s tone is one of disbelief and lacks real analysis which would uncover that others in the field like Old Dominion University researchers have similar conclusions the this EVMS doctor. Not too mention that it contained false information that had to be corrected or amended later. I Fe it, the headline was touting a cure but the analysis of your article was clearly lacking to be so negative on this doctor’s work. Just my humble opinion.

Kevin Lomangino

March 30, 2017 at 7:57 am

John,

Thanks for your comment but I respectfully disagree. Our criticism was reserved for how the study was promoted by the institution and covered by news organizations. The research itself is certainly interesting and bears follow-up in additional studies, as it no doubt will be. If it pans out, which we hope will happen but is unlikely based on past experience, then the talk of “cure” and other grandiose claims will be justified and welcome.

Kevin Lomangino Managing Editor

Dan Doherty

March 30, 2017 at 1:05 pm

I’m not a doctor, but I know a lot about the basics of research. Is this an observational study? Technically yes, but not in as worrisome a way as is typical. The standard problem with observational studies is that those who received “treatment” A are likely fundamentally different from those who received “treatment” B. For example, the type of person who regularly takes vitamin C supplements is likely different in many, many ways from the type of person who doesn’t. This is called the problem of lurking variables, and is (by far) the primary reason why a rigorous randomized clinical study is the gold standard. But are we really that worried that the 47 who had sepsis before the researcher started using the cocktail were fundamentally different from the 47 who had it after? By chance — possibly yes. But that is also possible with a randomly assigned treatment when one’s study is this small. (Second typical concern: Are we really worried that the lack of a double-blind protocol hindered the evaluation of the patients? I can’t say I am, as the variation in outcomes is not subtle in this case.) So my only lingering worry is about sample size. But if a few more doctors start doing this, and they see similar before/after differences, then I will simply be sad that this discovery was not made 16 years earlier, in time to help my mother.

Timothy Breuninger

March 30, 2017 at 1:17 pm

If you or your loved one were in the ICU with sepsis, wouldn’t you try this new formula?

Kevin Lomangino

March 30, 2017 at 1:31 pm

Whether or not the treatment is worth trying is totally separate from the issue of how this study was reported. Apples and oranges.

Dan Doherty

March 30, 2017 at 3:04 pm

But if people didn’t know about the treatment (through publicity such as NPR’s), then their loved one would get it only if their doctor happened to be one who had already decided to use it.

Norma Pionk

April 21, 2017 at 11:20 pm

I had lost my newborn son to sepsis on March 20th, 2017, two days after he was born. His organs were failing, had severe shock, on three different vasodepressors to increase his bp and was hooked up to an ECMO machine. Had I known of this treatment, I would’ve urged the physician’s to at the very least try, there was nothing else to lose.

Peter Lipowicz

March 30, 2017 at 5:13 pm

There is no large patient advocacy group or pharma company to tout these results so had they not made it into the mainstream media it is likely they would languish. Certainly the publicity will accelerate any subsequent testing and verification. And here is where you have to make a judgment about where this will pan out. If you think the evidence is weak and won’t be replicated then accelerated testing just wastes resources. I am a scientist, but not a doctor, and I think the evidence looks compelling and quite different from the type of evidence found in studies that are readily overturned. So I welcome the attention given that will give us a quick answer to whether these results are indeed too good to be true.

Ronald Santasiero MD

March 31, 2017 at 2:48 am

As usual main stream medicine treats a successful study utilizing vitamins as “non-resarch”. This is another example of main stream medicine criticizing a study utilizing natural treatments as poor research. If you substitute a new antibiotic instead of vitamin C in the study, it would be hailed as revolutionary. I have in fact used very high doses of IV vitamin C for infections, including viral infections, with great success for years. It is very safe, even at high doses, 50,000 mgs in a single IV dose. Doctors who use it regularly even go to doses as high as 100,000 mg. This is a pilot study for sure, but demands further investigation. As physicians we should be supportive of these novel approaches, as they are relatively cheap, effective and relatively safe. Physicians and scientists need to stop assuming a natural treatment cannot be as good as pharmaceuticals, because they are more potent. Many times physicians are under the assumption that if it is not in a main stream journal or we didn’t learn it in medical school it cant be true.

Deb Dennis

March 31, 2017 at 3:55 pm

I believe that the media has a responsibility to promote potentially life-saving news as widely as possible. And sadly that means extravagant headlines. Mainstream media uses this tactic every day to draw more readers, watchers, etc. It uses attention grabbing headlines- as you did in this article with “don’t hold your breath” cynicism. The pharmaceutical industry has spent billions on research looking for a “new drug” to treat Sepsis, you neglect to mention, do not know, or choose to ignore that that same industry receives NO funding for researching supplements. I am happy to see this story spread and shared, all too often if a vitamin is mentioned in treatment we automatically think “quack”. If you want responsible journalism then do your research- translate the studies in rats (etc) over the last 2 years into common terms for the edification of the general public. Remind them that it is only IV administered Vit-C & Thiamine used in combination with a specific Drug that creates this effect. Bring the science down to everyday level- so people Don’t jump the gun and start taking mega doses of any vitamin without getting the Facts- from you! Perhaps remind them that the human body is miraculous and complex – IDK, I read the other studies, it’s only during the extreme stress illness state that IV C is beneficial because oral vits are not available in plasma rapidly enough. I think it is a journalists responsibility to get people to think- sure – but also to educate. Thank you for this opportunity to view and think about my position on this.

Julie Miller

April 3, 2017 at 2:12 pm

The definition of sepsis is not a blood stream infection, that is bacteremia. The definition of sepsis is SIRS (which is an indication of a systemic inflammatory response) plus a known or likely source of infection. The infection could very well be caused by bacteremia however it is just one of many causes of sepsis.

Kevin Lomangino

April 3, 2017 at 2:20 pm

This post doesn’t define sepsis as a bloodstream infection. It says, “Sepsis occurs when an infection enters the bloodstream, spreads systemically, and triggers a cascading inflammatory response that can lead to widespread, multi-organ failure.”

Bruce Verson

April 6, 2017 at 4:55 am

“This realization might tempt some — like this NBC affiliate in Denver — to erroneously conclude that Dr. Marik has “found a simple, inexpensive cure for sepsis.”” 9NEWS in Denver simply stated that Dr. Marik “believes he found a simple, inexpensive cure for sepsis.” The word “believes” was omitted by Joyce, who earned an MA in health journalism. And the article concluded: “Next step: further research across a much larger patient population.” Patents with sepsis predictably have very low serum vitamin C levels. Dr. Marik used 1.5g of vitamin C per dose, 6g total per day. In the above article O’Brien said about vitamin C: “We don’t know if there are toxicities or not.” From rxlist.com: “….as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.” But calling the Eastern Virginia Medical School news release “egregious hype” is from the NY Post school of tabloid journalism.

Kevin Lomangino

April 6, 2017 at 6:53 am

Adding a weak qualifier to Marik’s statements claiming a “cure” and burying one note of caution at the end of the piece do very little to mitigate the egregious hype that was appropriately called out in this post.

Kevin Lomangino Managing Editor

kris west

April 9, 2017 at 3:04 pm

I’m not a doctor and not a scientist…but I do feel that CDC, FDA, pharmaceuticals and science who dispels the data that a natural treatment such as vitamin C has successfully treated many patients feel they have to run studies that will potentially change the cocktail and mess with the results so that the outcomes might be very different. I have a family member who has multiple autoimmune diagnoses and chronic lyme (which all of these, in my mind, are septic diseases) and wonder if this treatment could help her? All of this gives me great pause for thought, and hope for future treatments without the toxicity side effects.

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